Process Engineer

2 weeks ago

Simpang Empat, Penang, Malaysia Pentamaster Corporation Berhad (Official) Full time 60,000 - 180,000 per year

Medical Device Process Engineer

Overview:
We are seeking a skilled Medical Device Process Engineer to join our team. This role involves designing, developing, and optimizing manufacturing processes for medical devices, ensuring compliance with industry regulations and quality standards.

Key Responsibilities:

  • Develop and optimize manufacturing processes for medical devices, focusing on efficiency, quality, and safety.
  • Collaborate with R&D, quality assurance, and production teams to ensure seamless transition from design to manufacturing.
  • Conduct process validations and perform risk assessments to identify and mitigate potential issues.
  • Analyze production data to identify trends and areas for improvement.
  • Implement process control strategies to maintain product quality and consistency.
  • Prepare and maintain documentation for process specifications, work instructions, and standard operating procedures.
  • Lead root cause analysis and corrective action initiatives for process-related issues.

Qualifications:

  • Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Chemical Engineering, or a related field.
  • 3+ years of experience in process engineering within the medical device or related industry.
  • Strong knowledge of FDA regulations, ISO standards, and quality systems.
  • Proficiency in statistical process control (SPC) and process improvement methodologies (e.g., Six Sigma, Lean).
  • Excellent problem-solving skills and attention to detail.
  • Strong communication and teamwork abilities.

Preferred Skills:

  • Experience with CAD software and process simulation tools.
  • Familiarity with materials used in medical device manufacturing.
  • Project management experience is a plus.

This role offers the opportunity to impact the design and manufacturing of cutting-edge medical devices. If you are passionate about improving processes and ensuring product quality, we encourage you to apply

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